Recruiting

QT Syndrome

Sponsor:

Narrows Institute for Biomedical Research

Code:

NCT04169100

Conditions

Long QT Syndrome

Connective Tissue Diseases

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Prednisone

Study Details

Brief summary:

The goal of this study is to determine whether anti-Ro/SSA antibodies are associated with acquired QT prolongation in subjects with connective tissue disease. The investigators will investigate whether gender or race influence correlation between anti-Ro antibody status and prolonged QT interval and the role of inflammatory cytokines in association with anti-Ro antibodies and QT prolongation. The investigators propose to add an additional objective to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.

Conditions

Long QT Syndrome

Connective Tissue Diseases

Rheumatoid Arthritis

Study ID

NCT04169100

Start date

Sep 28, 2011

Status verified date

Apr, 2022

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- Patients enrolled in New York Harbor Healthcare System with connective tissue disease

Exclusion Criteria:

  • Atrial fibrillation
  • Intraventricular conduction delay with wide QRS complex
  • Acute medical conditions
  • Drug overdose
  • Hypothermia
  • Known diagnosis or family history of hereditary Long QT syndrome, complete bundle brunch block, ventricular paced rhythm, profound bradycardia and tachycardia, and uncorrected hypothyroidism

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prednisone Group

These patients have CTD and QTc over 500 msec. Prednisone is administered as a preventative measure against arrhythmia via QTc shortening.

Interventions

Prednisone

We propose to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.

Primary outcome measure

  • Change in Corrected QT Interval [ Time Frame: Baseline and at 14 days ]

Central Contacts and Locations

Central contacts

Deana Lazaro, MD

7188366600deana.lazaro@va.org

Locations

VA New York Harbor Healthcare System, NY and Brooklyn Campuses

Recruiting

New York, New York, United States, 11209

Contacts

Deana Lazaro, MD

718-836-6600deana.lazaro@va.gov

More Information

Sponsor

Narrows Institute for Biomedical Research

Last update posted

Apr 11, 2022

Last verified

Apr, 2022

Keywords

  • cytokines

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Narrows Institute for Biomedical Research on 2022-04-11.